Home Applications 022030 Application 022030
Type NDA
Sponsor PFIZER Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TOVIAZ FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 4MG Yes No 002 TOVIAZ FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL 8MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022030-001 TOVIAZ FESOTERODINE FUMARATE 4MG TABLET, EXTENDED RELEASE / ORAL AB RLD 2008-10-31 N022030-002 TOVIAZ FESOTERODINE FUMARATE 8MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2008-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022030-001 7807715 2027-06-07 U-913 Drug product N022030-001 8088398 2027-06-07 U-913 Drug product N022030-001 8501723 2027-06-07 Drug product 2013-08-20 N022030-001 7807715*PED 2027-12-07 Pediatric extension N022030-001 8088398*PED 2027-12-07 Pediatric extension N022030-001 8501723*PED 2027-12-07 Pediatric extension N022030-002 7807715 2027-06-07 U-913 Drug product N022030-002 8088398 2027-06-07 U-913 Drug product N022030-002 8501723 2027-06-07 Drug product 2013-08-20 N022030-002 7807715*PED 2027-12-07 Pediatric extension N022030-002 8088398*PED 2027-12-07 Pediatric extension N022030-002 8501723*PED 2027-12-07 Pediatric extension
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N022030-001 TOVIAZ 4MG TABLET, EXTENDED RELEASE / ORAL AB RLD 2008-10-31 a50c72e98297…2026-08-01 22:54:32 2026-06 N022030-002 TOVIAZ 8MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2008-10-31 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N022030-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 N022030-002 AB 1 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N022030-001 7807715 2027-06-07 U-913 Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N022030-001 8088398 2027-06-07 U-913 Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N022030-001 8501723 2027-06-07 Drug product 2013-08-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N022030-001 7807715*PED 2027-12-07 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022030-001 8088398*PED 2027-12-07 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022030-001 8501723*PED 2027-12-07 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022030-002 7807715 2027-06-07 U-913 Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N022030-002 8088398 2027-06-07 U-913 Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N022030-002 8501723 2027-06-07 Drug product 2013-08-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N022030-002 7807715*PED 2027-12-07 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022030-002 8088398*PED 2027-12-07 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022030-002 8501723*PED 2027-12-07 Pediatric extension a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 40 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0069-0242 Toviaz fesoterodine fumarate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0242 Toviaz fesoterodine fumarate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0242 Toviaz fesoterodine fumarate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0242 Toviaz fesoterodine fumarate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0242 Toviaz fesoterodine fumarate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0242 Toviaz fesoterodine fumarate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0242 Toviaz fesoterodine fumarate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0242 Toviaz fesoterodine fumarate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0244 Toviaz fesoterodine fumarate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0244 Toviaz fesoterodine fumarate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0244 Toviaz fesoterodine fumarate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0244 Toviaz fesoterodine fumarate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0244 Toviaz fesoterodine fumarate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0244 Toviaz fesoterodine fumarate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0244 Toviaz fesoterodine fumarate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0244 Toviaz fesoterodine fumarate Pfizer Laboratories Div Pfizer Inc NDA Current 55154-2737 Toviaz fesoterodine fumarate Cardinal Health NDA Current 55154-2737 Toviaz fesoterodine fumarate Cardinal Health NDA Current 55154-2737 Toviaz fesoterodine fumarate Cardinal Health NDA Current 55154-2738 Toviaz fesoterodine fumarate Cardinal Health NDA Current 55154-2738 Toviaz fesoterodine fumarate Cardinal Health NDA Current 55154-2738 Toviaz fesoterodine fumarate Cardinal Health NDA Current 63539-183 Toviaz fesoterodine fumarate U.S. Pharmaceuticals NDA Current 63539-183 Toviaz fesoterodine fumarate U.S. Pharmaceuticals NDA Current 63539-183 Toviaz fesoterodine fumarate U.S. Pharmaceuticals NDA Current 63539-183 Toviaz fesoterodine fumarate U.S. Pharmaceuticals NDA Current 63539-183 Toviaz fesoterodine fumarate U.S. Pharmaceuticals NDA Current 63539-183 Toviaz fesoterodine fumarate U.S. Pharmaceuticals NDA Current 63539-183 Toviaz fesoterodine fumarate U.S. Pharmaceuticals NDA Current 63539-183 Toviaz fesoterodine fumarate U.S. Pharmaceuticals NDA Current 63539-242 Toviaz fesoterodine fumarate U.S. Pharmaceuticals NDA Current 63539-242 Toviaz fesoterodine fumarate U.S. Pharmaceuticals NDA Current 63539-242 Toviaz fesoterodine fumarate U.S. Pharmaceuticals NDA Current 63539-242 Toviaz fesoterodine fumarate U.S. Pharmaceuticals NDA Current 63539-242 Toviaz fesoterodine fumarate U.S. Pharmaceuticals NDA Current 63539-242 Toviaz fesoterodine fumarate U.S. Pharmaceuticals NDA Current 63539-242 Toviaz fesoterodine fumarate U.S. Pharmaceuticals NDA Current 63539-242 Toviaz fesoterodine fumarate U.S. Pharmaceuticals NDA Current 69189-0242 Toviaz fesoterodine fumarate Avera McKennan Hospital NDA Current 69189-0244 Toviaz fesoterodine fumarate Avera McKennan Hospital NDA Current